GE Medical Systems, LLC: B125P Patient Monitor (with E-module slot option), REF 6160000-002

Hazard

GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

Details from the source

Reason for recall: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level. Distribution: Worldwide distribution. Quantity: 388 units Lot/code info: UDI/DI 00840682147224: Model Number 6160000-002-100174, Serial Numbers: SR522350004WA, SR522350001WA, SR522350002WA, SR522350003WA, SR522350005WA, SR522350006WA, SR522350007WA, SR522350008WA, SR522350009WA, SR522350010WA, SR522350011WA, SR522350012WA, SR522350013WA, SR522350014WA, SR522350015WA, SR522350016WA, SR522350017WA, SR522350018WA, SR522350019WA, SR522350020WA, SR522350021WA, SR522350047WA, SR522350048WA, SR522350049WA, SR522350050WA, SR522350088WA, SR522350051WA, SR522350053WA, SR522350054WA, SR522350055WA, SR522350087WA, SR522350089WA, SR522350090WA, SR522350091WA, SR522350092WA, SR522350093WA, SR522350094WA, SR522350095WA, SR522350096WA, SR522350097WA, SR522350098WA, SR522350168WA, SR522350165WA, SR522350166WA, SR522350167WA, SR522350169WA, SR522350170WA, SR522350171WA, SR522350172WA, SR522350173WA, SR522350174WA, SR522350175WA, SR522350176WA, SR522350177WA, SR522350178WA, SR522350179WA, SR522350183WA, SR522350180WA, SR522350181WA, SR522350182WA, SR522350160WA, SR522350161WA, SR522350162WA, SR522350163WA, SR522350164WA, SR522350135WA, SR522350136WA, SR522350137WA, SR522350138WA, SR522350139WA, SR522350140WA, SR522350141WA, SR522350142WA, SR522350143WA, SR522350144WA, SR522350145WA, SR522350146WA, SR522350147WA, SR522350148WA, SR522350149WA, SR522350150WA, SR522350151WA, SR522350152WA, SR522350153WA, SR522350155WA, SR522350156WA, SR522350157WA, SR522350158WA, SR522350159WA, SR522350111WA, SR522350112WA, SR522350116WA, SR522350113WA, SR522350114WA, SR522350115WA, SR5

UPC codes

00840682147224

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.